Pricing, reimbursement and access

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NICE backs Astellas’ Veoza for NHS use

The UK subsidiary of Japanese pharma major Astellas Pharma today announced that the National Institute for Health and Care Excellence (NICE) issued final draft guidance (FDG) recommending Veoza fezolinetant) 45mg once daily. 11 March 2026

SteinCares, Shilpa strike Latin America biosimilar licensing pact

Costa Rica-based specialty healthcare company SteinCares has signed a licensing agreement with India’s Shilpa Biologicals, part of Shilpa Medicare, to commercialize a biosimilar across Latin America. 11 March 2026

BeOne’s tislelizumab now available in Ireland

Sino-American oncology specialist BeOne Medicines today announced that the Health Service Executive (HSE) in the Republic of Ireland has approved reimbursement of tislelizumab, (trade name Tevimbra) in combination with platinum-based chemotherapy, for the first-line treatment of eligible adult patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (OSCC) whose tumors express PD-L1. 10 March 2026

ICER to review AbbVie’s Parkinson’s disease drug

The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of tavapadon, from AbbVie. 9 March 2026

EFPIA urges action to expand access to precision oncology

Europe’s research-based pharmaceutical industry group EFPIA has published a white paper calling for more coordinated efforts to reduce disparities in access to precision oncology treatments and biomarker testing across Europe. 9 March 2026

FDA meeting with States on importation of lower cost drugs

Earlier this past week, the US Food and Drug Administration held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer. 7 March 2026

ICER special report on treatment for UC and Crohn’s disease

US health technology assessor the Institute for Clinical and Economic Review (ICER) has posted a Special Report on Entyvio (vedolizumab, from Japan’s Takeda Pharmaceutical for the treatment of ulcerative colitis and Crohn’s disease. 4 March 2026

Lif urges election focus on patient access and competitiveness

Denmark’s pharmaceutical industry association Lif has called on politicians to make patient access to new medicines and the country’s life sciences sector a central issue in the general election campaign set for March 24. 2 March 2026

Santhera’s Agamree wins Spanish reimbursement

Switzerland’s Santhera Pharmaceuticals has announced that the Spanish Interministerial Commission on Prices of Medicines has proposed to include Agamree (vamorolone) in the pharmaceutical coverage of the National Health System, making it eligible for reimbursement. 27 February 2026

US states sue HHS over overhaul of childhood vaccine schedule

A coalition of 15 states has sued US Health and Human Services Secretary Robert F Kennedy Jr and senior federal health officials, seeking to block what they call a sweeping rewrite of the nation’s childhood immunization schedule. 26 February 2026

AbbVie’s $100B US deal and FDA reforms highlight growing focus on domestic manufacturing

US pharma major AbbVie’s $100 billion agreement with the US administration signals a structural recalibration of drug pricing negotiations, tying tariff exemptions and pricing flexibility directly to domestic manufacturing expansion. 25 February 2026

Novo Nordisk to cut Wegovy price by up to half

Denmark’s Novo Nordisk has announced—effective January 1, 2027—a lower $675 US list price, or wholesale acquisition cost (WAC), for Wegovy (semaglutide) injection 2.4mg and tablets 25mg, Ozempic (semaglutide) injection 0.5mg, 1mg, and 2mg, and Rybelsus (semaglutide) tablets 7mg or 14mg. 25 February 2026

NICE backs approval for Incyte’s Opzelura

US biopharma company Incyte’s UK subsidiary today announces that the National Institute for Health and Care Excellence (NICE) has approved the reimbursement of Opzelura (ruxolitinib) cream 15mg/g for eligible patients with non-segmental vitiligo on the National Health Service (NHI). 24 February 2026

Questions mount over 340B program and increased cost to everyone

Congressional scrutiny of the USA’ 340B Program is intensifying, with Senate HELP Committee chairman Dr Bill Cassidy, (R-La.) expanding his investigation into 340B to include Apexus, a Texas-based private, for-profit firm that contracts with the government to manage the 340B program. 24 February 2026

Swiss KVV revision slammed by Interpharma

Since the adoption of the second cost-containment package, the international landscape has fundamentally changed – particularly due to the new US pricing policy, which will have a direct impact on the availability of innovative medicines in Switzerland, according to the Swiss pharma trade group Interpharma. 23 February 2026

Pricing and reimbursement delays critical headwind for biopharma innovation

Delays in turning approved medicines into revenue, driven by pricing and reimbursement (P&R) processes, have emerged as one of the most critical challenges facing the pharmaceutical industry over the next year. 17 February 2026

Annual Canada Health Act report earmarks $62 million in deductions

Canada’s federal health minister, Marjorie Michel, has tabled the 2024-2025 Canada Health Act Annual Report in Parliament, outlining how provincial and territorial health insurance plans are meeting the law’s requirements. 16 February 2026

AstraZeneca’s Imfinzi wins NICE nod as first perioperative IO treatment for MIBC

Anglo-Swedish drugmaker AstraZeneca has announced a positive recommendation from the National Institute for Health and Care Excellence (NICE) for Imfinzi (durvalumab), a perioperative treatment regimen for cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC). 10 February 2026

EU urged to make pharma central to competitiveness debate

European industry group the European Federation of Pharmaceutical Industries and Associations (EFPIA) is pressing EU leaders meeting in Belgium to treat the research-based pharmaceutical sector as a strategic pillar of competitiveness and resilience. 9 February 2026

HHS drops 340B rebate pilot after court setback

The US Department of Health and Human Services has agreed to abandon a proposed rebate-based pilot for the 340B drug pricing program, marking a clear win for hospital groups that argued the scheme would strain safety-net providers serving low-income patients. 9 February 2026

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The microbiome searches for a second act

The microbiome sector has approved medicines on the market, but it has not yet delivered the broad therapeutic class that early investors once expected. Its current phase is more focused, with companies trying to show that gut bacteria can be developed into consistent, regulated products with clear clinical uses. 17 June 2026

Regulatory round-up: 15 June 2026

Regulators delivered a fairly busy week, led by a cluster of US Food and Drug Administration oncology decisions and two new UK approvals from the Medicines and Healthcare products Regulatory Agency. The FDA cleared new uses for Welireg with Keytruda in renal cell carcinoma and Truqap in a PTEN-deficient prostate cancer setting, while the MHRA authorized the UK’s first GLP-1 tablet for weight management. 15 June 2026

CMS proposed rule locks in Medicare Drug Price Negotiation Program

A new proposal from the US Centers for Medicare & Medicaid Services (CMS) would establish a permanent framework for the Medicare Drug Price Negotiation Program (Negotiation Program), creating a more transparent and sustainable process for lowering drug costs for millions of Medicare beneficiaries. 15 June 2026

India’s pharma role is expanding beyond generics

India’s pharma industry is still best known for low-cost generic medicines, vaccines, active ingredients and contract manufacturing. That role remains central to global drug supply, but it no longer describes the full direction of the sector. 12 June 2026

PwC warns US healthcare costs are becoming harder to tame

PwC expects US commercial healthcare costs to remain high in 2027, with health plans facing pressure from provider billing, hospital reimbursement, pharmacy spending, behavioral health demand and out-of-network arbitration. 12 June 2026

Pharma trade bodies press G7 leaders on innovation agenda

The global branded drug industry has urged G7 leaders to put pharmaceutical innovation at the center of their economic agenda, in a pre-summit statement that also serves as a clear pitch for policies more favorable to the sector. 11 June 2026

Pfizer weighs German investment as peers push back on reform

US pharma giant Pfizer is reviewing the timing and scope of planned investments in Germany, as industry anger builds over proposed healthcare reforms that could lower drug prices in one of Europe’s largest pharma markets. 11 June 2026

NICE backs AbbVie’s Aquipta for acute migraine treatment

US pharma major AbbVie has secured a recommendation from the UK’s National Institute for Health and Care Excellence for Aquipta (atogepant) as an acute treatment option for adults with migraine. 10 June 2026

ICER final evidence report on treatment for narcolepsy

The USA’s Institute for Clinical and Economic Review (ICER) released a Fina; Evidence Report assessing the comparative clinical effectiveness and value of oveporexton (TAK-861), from Japan’s Takeda Pharmaceutical for narcolepsy type 1. 9 June 2026

US Supreme Court backs Hikma in skinny-label patent fight

The US Supreme Court has handed a unanimous win to British drugmaker Hikma in a closely watched generics patent case brought by Irish biopharma Amarin. 5 June 2026

Gilead’s Livdelzi approved by NICE for PBC

US drugmaker Gilead Sciences today announced that the UK’s National Institute for Health and Care Excellence (NICE) has approved Livdelzi (seladelpar) for the use on the National Health Service (NHS) in England within its marketing authorization as an option for treating primary biliary cholangitis (PBC). 4 June 2026

Is the W.A.I.T. indicator making access to medicines worse?

In this week’s Expert View, Cem Zorlular, CEO of Er-Kim, argues that Europe’s W.A.I.T. indicator is becoming too blunt to capture how patients actually access medicines. He says the index risks deterring investment in markets where viable access routes already exist. 3 June 2026

Ireland reimburses BeOne’s Brukinsa for relapsed marginal zone lymphoma

Oncology company BeOne Medicines says Brukinsa (zanubrutinib) has secured reimbursement in Ireland for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. 1 June 2026

Advicenne granted reimbursement for Likozam in France

Shares of French pharma Advicenne leapt almost 50% to 1.31 euros this morning, after it announced that Likozam (clobazam) is reimbursed by the French social security system, notably for the combination treatment of drug-resistant epilepsy. 1 June 2026

Hetronifly wins NICE backing in tough lung cancer niche

UK-based Accord Healthcare has won a National Institute for Health and Care Excellence recommendation for Hetronifly (serplulimab) in untreated extensive-stage small cell lung cancer, opening routine NHS access in England and Wales for a disease where progress has been stubbornly slow. 29 May 2026

PhRMA uses cancer research month to warn on pricing

The Pharmaceutical Research and Manufacturers of America has used National Cancer Research Month to argue that US cancer research leadership could weaken if pricing and reimbursement policies reduce incentives for drug development. 29 May 2026

NICE recommends Nucala for uncontrolled COPD

GSK today announced that NICE has issued draft final guidance recommending Nucala (mepolizumab) for use on the National Health Service (NHS), as an add-on maintenance treatment option for adult patients with uncontrolled COPD. 28 May 2026

Foundayo and Zepbound now covered by CVS

US pharma major Eli Lilly today announced an access milestone in obesity care: all three of the nation's largest pharmacy benefit managers (PBMs) will cover Lilly's full obesity medicine portfolio. 28 May 2026

Belgian is where biosimilars belong

In recent years, some stakeholders have held the view that Belgium is a difficult or even unattractive country for biosimilars, according to a website posting by trade group pharma.be. 26 May 2026

NICE recommends Genmab’s Tivdak

The UK’s National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending the use of Tivdak (tisotumab vedotin), an antibody-drug conjugate (ADC), from within its marketing authorization for the monotherapy treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. 22 May 2026

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